Randomized clinical trial of varicose vein surgery with compression versus compression alone for the treatment of venous ulceration

Abstract

Objectives: No randomized controlled trials exist to show whether varicose vein surgery improves healing of venous ulcers. In this study we investigated whether superficial venous surgery gave additional benefit to compression therapy in terms of healing rate, time to healing and quality of life of patients with venous ulcers.

Methods: A total of 121 consecutive patients with venous ulceration were identified, of which 45 were unfit/unwilling to be included. The remaining 76 (aged 38-89, 39 female) were randomized to receive either four-layer bandaging (n =39) or superficial venous surgery (long and short saphenous with or without perforator surgery) and four-layer bandaging (n =37). Ulcer healing and health-related quality of life (HRQL) were assessed.

Results: The healing rate was 64% (25/39) in the compression treatment group and 68% (25/37) in the surgical treatment group. This difference was not statistically significant (Pearson ² P=0.75). There was no significant difference between the time to ulcer healing in the two treatment groups (log rank statistic=0.69, P value=0.41): median time 83 days for surgery vs 98 days for compression. After adjusting for duration of ulcer, size of ulcer and previous deep vein thrombosis, there was still no significant difference between time to healing for the two treatment groups (adjusted hazard ratio=0.79, 95% confidence interval 0.45-1.39). There was no difference in HRQL between the two groups, using the scores of a disease-specific questionnaire (CXVUQ).

Conclusions: This study suggests that for venous ulceration, superficial venous surgery gives no additional benefit to compression therapy from the point of view of healing rate and quality of life.